Breathable Impervious Gowns

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K012984 ↗

FDA Product Code

FYA

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K022765 Active Cleared 11 Oct 2002

• Powder Free Sterile Latex Examination Gloves

  Class I

  FDA 510(k) K001141 Active Cleared 9 May 2000

• Sterile Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K010211 Active Cleared 15 Feb 2001

• Ultraderm Sterile Latex Powdered Surgical Sloves with Protein Content Labeling Claim (50 Micrograms or Less)

  Class I

  FDA 510(k) K991205 Active Cleared 13 Oct 1999

• Convertors Drape Material

  Class II

  FDA 510(k) K964125 Active Cleared 23 Dec 1996

• Convertors Impervious Shoe Covers

  Class I

  FDA 510(k) K970815 Active Cleared 27 Mar 1997

See all devices from Allegiance Healthcare Corp. →

• What are Breathable Impervious Gowns designed for?

  These gowns are specifically engineered for surgical settings to protect healthcare personnel and patients from contamination during procedures. Their composite fabric structure—combining nonwoven layers with a breathable impervious film—balances fluid resistance with moisture vapor transmission, ensuring both safety and comfort during general and plastic surgery.

• Are Breathable Impervious Gowns single-use or reusable?

  These gowns are intended for single-use only. The design prioritizes fluid resistance and sterility, making them disposable to maintain hygiene standards in surgical environments. Reuse could compromise their protective integrity and increase infection risks.

• What storage conditions should be followed for these gowns?

  While specific storage instructions aren’t detailed in regulatory data, these gowns should be kept in a clean, dry environment until use. Proper storage prevents contamination and ensures the fabric’s performance, particularly the breathable impervious film, remains intact.

• What types of surgical procedures are these gowns authorized for?

  The Breathable Impervious Gowns are authorized for use in general and plastic surgery procedures. Their FDA clearance (K012984) under product code FYA confirms their suitability for these settings, where fluid resistance and breathability are critical.

• How do these gowns differ from standard surgical gowns?

  Unlike traditional surgical gowns, these feature a monolithic breathable impervious film integrated into the fabric, allowing moisture vapor to escape while blocking fluids. This design enhances comfort for prolonged wear in operating rooms without sacrificing protection.